We have read with interest the recent cases suggesting the possibility of vaccine-induced immune-mediated hepatitis with Pfizer-BioNTech and Moderna mRNA-1273 vaccines for the SARS-CoV-2 virus., , , , , ,  However, as the cohort of vaccinated individuals against COVID-19 increases, the previously reported cases could not exclude a coincidental development of autoimmune hepatitis, which has an incidence of 3/100,000 population per year.8 Our case demonstrates conclusive evidence of vaccine-induced immune-mediated hepatitis with a rapid onset of liver injury after the first Moderna dose, which on re-exposure led to acute severe autoimmune hepatitis.
A 47-year-old Caucasian man, previously completely well, received his 1st Moderna vaccine dose on the 26 April 2021. He noted malaise and jaundice 3 days after. Investigations on the 30th April showed serum bilirubin 190 μmol/L (normal 0-20), alanine aminotransferase (ALT) 1,048 U/L (normal 10-49), alkaline phosphatase (ALP) 229 U/L (normal 30-130), albumin 41 g/L (normal 35-50). Blood count, renal function and international normalized ratio (INR) were normal. Liver function tests (LFTs) last checked 4 years previously were normal. He denied paracetamol use and reported minimal alcohol intake. Ultrasound scan, CT thorax, abdomen and pelvis and MRI pancreas performed to exclude malignancy, showed no significant findings. Serum IgG was raised at 25.1 g/L (normal 6-16), IgM 2.2 g/L (0.5-2) and serum was positive for anti-nuclear antibody. Serological tests for HAV, HBV, HCV, HEV, EBV and CMV were negative.
His jaundice faded and LFTs improved: bilirubin falling on 25th June to 69 μmol/L and ALT to 332 U/L. The patient received his 2nd Moderna vaccine dose on the 6 July 2021 (despite reporting the jaundice to the vaccination centre) and the jaundice returned a few days after. Blood tests on 20th July found bilirubin 355 μmol/L, ALT 1,084 U/L and a raised prothrombin time (PT) of 18.4 seconds. After liver biopsy on the 21st July 2021, prednisolone 40 mg/day was commenced and he was transferred to our service.